Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Last updated: June 27, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Cutaneous Lupus Erythematosus

Musculoskeletal Diseases

Lupus

Treatment

Placebo

Ianalumab

Clinical Study ID

NCT06133972
CVAY736F12301E1
2023-505929-14-00
2023-505929-14
  • Ages 12-100
  • All Genders

Study Summary

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Signed informed consent prior to participation in the extension study. Parent orlegal guardian's signed informed consent and child's assent, if appropriate, arerequired before any assessment is performed for participants <18 years of age. Ofnote, if the participant reaches age of consent (age as per local law) during thestudy, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.

  • Participants must have participated in either one of the two SIRIUS-SLE corestudies, CVAY736F12301 or CVAY736F12302, and have completed the treatment periodthrough Week 60 without treatment discontinuation.

  • In the judgement of the investigator, participants must be expected to clinicallybenefit from continued study treatment.

Exclusion

Key Exclusion Criteria:

  • Use of prohibited therapies.

  • Active viral, bacterial or other infections requiring intravenous or intramusculartreatment for clinically significant infection which in the opinion of theinvestigator will place the participant at risk for participation.

  • Plans for administration of live vaccines during the study period.

  • Pregnant or nursing (lactating) women.

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, refusing or unable to use highly effective methods ofcontraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).

  • United States (and other countries, if locally required): sexually active males,unless they agree to use barrier protection during intercourse with women ofchild-bearing potential while taking study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 21, 2024
Estimated Completion Date:
December 23, 2031

Study Description

The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    San Miguel, Buenos Aires 1663
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    San Miguel de Tucuman, Tucuman T4000CBC
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Tucuman, 4000
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Maroochydore, Queensland 4558
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Salvador, BA 40150 150
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Barretos, Sao Paulo 14784 400
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Novartis Investigative Site

    Rimouski, Quebec G5L 5T1
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shantou, Guangdong 515041
    China

    Active - Recruiting

  • Novartis Investigative Site

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Novartis Investigative Site

    Pingxiang, Jiangxi 337000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Chang Chun, Jilin 130021
    China

    Active - Recruiting

  • Novartis Investigative Site

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Novartis Investigative Site

    Urumqi, Xinjiang 830001
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100069
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shanghai, 200127
    China

    Active - Recruiting

  • Novartis Investigative Site

    Zhejiang, 315016
    China

    Active - Recruiting

  • Novartis Investigative Site

    Medellin, Antioquia 050001
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Barranquilla, Atlantico 080020
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Chia, Cundinamarca 250001
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Bogota, 111611
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Brno, 63800
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Montpellier 5, 34295
    France

    Active - Recruiting

  • Novartis Investigative Site

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75014
    France

    Active - Recruiting

  • Novartis Investigative Site

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Guatemala, 01010
    Guatemala

    Active - Recruiting

  • Novartis Investigative Site

    Guatemala City, 01010
    Guatemala

    Active - Recruiting

  • Novartis Investigative Site

    Szekesfehervar, Fejer 8000
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Ahmedabad, Gujarat 380006
    India

    Active - Recruiting

  • Novartis Investigative Site

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Nagoya, Aichi 457 8510
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, Seocho Gu 06591
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Ciudad de Mexico, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Leon, Guanajuato 37160
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Guadalajara, Jalisco 44160
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Merida, Yucatan 97070
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Mexico, 07760
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Wroclaw, Dolnoslaskie 52-210
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Bydgoszcz, 85-065
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Bytom, 41 902
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Warszawa, 00-874
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Braga, 4710243
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Brasov, 500283
    Romania

    Active - Recruiting

  • Novartis Investigative Site

    Cluj Napoca, 400006
    Romania

    Active - Recruiting

  • Novartis Investigative Site

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Badalona, Catalunya 08916
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, Catalunya 08003
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28034
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Novartis Investigative Site

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Novartis Investigative Site

    Bangkok, 10400
    Thailand

    Active - Recruiting

  • Pinnacle Research Group Llc

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Pinnacle Research Group Llc .

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Advanced Medical Research

    La Palma, California 90623
    United States

    Active - Recruiting

  • Millennium Clinical Trials

    Westlake Village, California 91361
    United States

    Active - Recruiting

  • Clinical Res Of W Florida

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Clinical Res. of W Florida

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Lake Charles, Louisiana 70601
    United States

    Active - Recruiting

  • Ahmed Arif Medical Research Center

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Shelby Research LLC

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Novel Research LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.